Binge Eating DisorderNCT04432311
Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of BED
A study testing Binge Focused Therapy (BFT) and CBT Unguided Self Help (CBT USH) in people with Binge Eating Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Binge Focused Therapy (BFT) and CBT Unguided Self Help (CBT USH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2021to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnosis of BED (mild-extreme) as per Eating Disorder Examination - Mild severity will be modified from a minimum of 1 objective binge episode/week to 2 objective binge episodes per week
- Age 18 or older
- Access to computer with internet connection and webcam that can be used in a private area
- Virtually signed informed consent form
Who cannot join
- Currently receiving psychotherapy/treatment for BED (as determined by PI)
- Self-reported Body Mass Index on pre-screening questionnaire < 20 kg/m2
- Dose change of a psychotropic medication used for the treatment of BED (e.g., Vyvanse, topiramate, antidepressants) or any medication that could have an effect on appetite/binging (e.g., Saxenda) within 4 weeks of study inclusion (as determined by PI)
- Insufficient knowledge of English
- Previously participated in proof-of-concept BFT study
- Previously read Overcoming Binge Eating by C. Fairburn and implemented strategies presented in the book (as determined by PI)
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- Serious physical illness (e.g., severe uncontrolled insulin dependent diabetes) (as determined by PI)
- Currently pregnant
- Scores greater than 20 on the Quick Inventory of Depressive Symptomatology Self-Report and PI determines participant is significantly depressed (as determined by PI)
- Currently experiencing serious issues with alcohol or drugs (as determined by PI)
- Currently engaging in self-harm behaviours (as determined by PI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of Binge Eating Disorder
Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. BED is associated with an increased risk of health complications, significant impairment to social and occupational functioning, and reduced quality of life. Despite the negative consequences associated with this disorder, standard therapy for BED is often inaccessible and costly.
To address the limitations of standard therapy for BED our research team has developed Binge Focused Therapy (BFT) as an innovative, guided self-help approach to BED treatment. BFT was derived from elements of "The Brain Over Binge Recovery Guide" by Kathryn Hansen, which incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behaviour Therapy, Motivational Enhancement Therapy, and addictions treatment. We further streamlined this approach into a protocol that can be delivered by non eating disorder specialists (e.g., honours psychology students, nurses, occupational therapists).
Read more
In 2018, our research team conducted a proof-of-concept pilot study with a sample of 40 individuals with BED. Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general eating disorder symptomology, and improved confidence in changing binge eating behaviours.
Although the results from this small, uncontrolled, proof-of-concept study are encouraging, qualitative and quantitative data highlighted several aspects of the BFT intervention that could be altered and tested in a randomized controlled trial that compares BFT to an active comparator.
- Conditions
- Binge Eating Disorder
- Being tested
- Binge Focused Therapy (BFT), CBT Unguided Self Help (CBT USH)
- Keywords
- Binge Eating Disorder, Binge Focused Therapy (BFT), Self-Help, Guided Self-Help
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binge Focused Therapy (BFT)Behavioural
The BFT group will be provided Binge Focused Therapy, a group-based, guided-self help intervention. Participants in this group will attend three online group sessions spread over six weeks (Week 1, Week 2, and Week 6) and complete homework between sessions. Following Session 3, there is a four week period where participants complete self-guided check-ins once per week to monitor continued progress and/or signs of relapse.
CBT Unguided Self Help (CBT USH)Behavioural
The CBT USH group will be provided with the book, Overcoming Binge Eating by C. Fairburn, which is a well-established self-help book used to help individuals understand binge eating and control binge eating behaviours. After participants receive the book, they will have 10 weeks to read it and work through the exercises provided in the book.
| Study group | Role | What they receive |
|---|---|---|
| Binge Focused Therapy (BFT) | Experimental | Guided self-help - Three online group sessions, homework, and self-guided check-ins to monitor continued progress and/or signs of relapse. Receives: Behavioral: Binge Focused Therapy (BFT) |
| CBT Unguided Self Help (CBT USH) | Active comparator | Pure self-help - The use of the book Overcoming Binge Eating and its associated homework. Receives: Behavioral: CBT Unguided Self Help (CBT USH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Symptomology
This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.
Measured: Baseline to Post-Treatment (10 week)
Secondary outcomes (10)
Binge Eating Symptomology
This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.
Measured: 6 week, 6-month follow-up, 12-month follow-up
Binge Eating Frequency
Self reported changes in Binge Eating Frequency over past 28 days will be measured using Item 15 from the Eating Disorder Examination Questionnaire 6.0 (EDE-Q; Fairburn \& Beglin, 1994) which inquires about the number of days with objective binge episodes over the past 28 days.
Measured: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)
Self reported changes in Eating Disorder Symptomology will be measured using the global score generated from the EDE-Q (Fairburn \& Beglin, 1994). The EDE-Q is a 28-item measure that assesses four areas of eating disorder psychopathology (eating concern, shape concern, weight concern, dietary restraint). Each item uses a Likert scale ranging from 0 (lowest frequency/severity) to 6 (highest frequency/severity). The global score ranges from 0-6 where higher scores indicate greater impairment. The global score is obtained using the mean of the four subscales.
Measured: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Clinical Impairment
Self reported changes in clinical impairment will be measured using the Clinical Impairment Assessment Questionnaire (CIA; Bohn \& Fairburn, 2008). This is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features over the past 28 days. Each item is ranked on a 0-3 scale (0 being "not at all" and 3 being "a lot"). Total scores range from 0-48, with higher scores indicating greater clinical impairment.
Measured: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Confidence to Change Binge Eating
Confidence to Change Binge Eating will be measured using the question, "On a scale from 1 to 10, how confident are you that you can change your binge eating if you wanted to?", with higher scores indicating greater confidence. This question assesses perceived confidence in ability to change binge eating.
Measured: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Abstinence
Abstinence is defined as a 100% reduction in binge episodes in the 28 days prior to collecting outcome measures.
Measured: Week 10, 6-month follow-up, 12-month follow-up
Remission
Remission is defined as meeting criteria for abstinence (100% reduction in binge episodes in the 28 days prior to collecting outcome measures) in addition to having EDEQ global score less than or equal to 2.77 (Fairburn \& Beglin, 1994).
Measured: Week 10, 6-month follow-up, 12-month follow-up
Intervention Adherence
Intervention adherence for participants in the BFT group will be based on session attendance. Completers will be defined as anyone who completes Session 1 and at least one other session. Adherence questionnaires at Week 6 and Week 10 time points inquire about which aspects of the intervention outside of the sessions have been used.
Intervention adherence for participants in the CBT USH group will be calculated using questionnaires provided at both the Week 6 and Week 10 time points that inquire about which chapters have been read and which "CBT Steps" have been completed thus far. Completers will be defined as anyone who indicates that they have read Chapters 1, 4, 5, and 'Getting Ready', and completed Step 1 through Step 3.
Measured: Week 6, Week 10
Participant Expectations
This will be measured using the Credibility and Expectancy Questionnaire (CEQ; Devilly \& Borkovec, 2000). The CEQ is a six item self-report measure that measures treatment expectancy and rationale credibility of therapeutic interventions. Each item is scored on a 1-9 Likert-type scale or as a percentage rating from 0% to 100% in increments of 10%. Higher scores indicate greater credibility/expectancy of the intervention.
Measured: Pre-Intervention, Week 1
Satisfaction with Intervention
Participants in both groups will respond to developed Likert-style and open-ended questions asking about their perceptions of their assigned program. Each Likert item is ranked on a scale from 1-9. Higher total scores indicate greater satisfaction with the intervention.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 Jan 2021
- Primary completion28 Jun 2022
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Keshen, Nova Scotia Health Authority
- Investigators
- Aaron Keshen, MD, FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432311
- Sponsor's protocol ID
- BFT 2.0
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04432311
- Acronym / sponsor ID
- BFT 2.0
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating Disorder, Binge Focused Therapy (BFT), Self-Help, Guided Self-Help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. BED is associated with an increased risk of health complications, significant impairment to social and occupational functioning, and reduced quality of life. Despite the negative consequences associated with this disorder, standard therapy for BED is often inaccessible and costly.
To address the limitations of standard therapy for BED our research team has developed Binge Focused Therapy (BFT) as an innovative, guided self-help approach to BED treatment. BFT was derived from elements of "The Brain Over Binge Recovery Guide" by Kathryn Hansen, which incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behaviour Therapy, Motivational Enhancement Therapy, and addictions treatment. We further streamlined this approach into a protocol that can be delivered by non eating disorder specialists (e.g., honours psychology students, nurses, occupational therapists).
In 2018, our research team conducted a proof-of-concept pilot study with a sample of 40 individuals with BED. Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general eating disorder symptomology, and improved confidence in changing binge eating behaviours.
Although the results from this small, uncontrolled, proof-of-concept study are encouraging, qualitative and quantitative data highlighted several aspects of the BFT intervention that could be altered and tested in a randomized controlled trial that compares BFT to an active comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge Focused Therapy (BFT) | Experimental | Behavioral: Binge Focused Therapy (BFT)Guided self-help - Three online group sessions, homework, and self-guided check-ins to monitor continued progress and/or signs of relapse. |
| CBT Unguided Self Help (CBT USH) | Active comparator | Behavioral: CBT Unguided Self Help (CBT USH)Pure self-help - The use of the book Overcoming Binge Eating and its associated homework. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnosis of BED (mild-extreme) as per Eating Disorder Examination - Mild severity will be modified from a minimum of 1 objective binge episode/week to 2 objective binge episodes per week
- Age 18 or older
- Access to computer with internet connection and webcam that can be used in a private area
- Virtually signed informed consent form
Key exclusion criteria (11 listed)
- Currently receiving psychotherapy/treatment for BED (as determined by PI)
- Self-reported Body Mass Index on pre-screening questionnaire < 20 kg/m2
- Dose change of a psychotropic medication used for the treatment of BED (e.g., Vyvanse, topiramate, antidepressants) or any medication that could have an effect on appetite/binging (e.g., Saxenda) within 4 weeks of study inclusion (as determined by PI)
- Insufficient knowledge of English
- Previously participated in proof-of-concept BFT study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binge Focused Therapy (BFT)The BFT group will be provided Binge Focused Therapy, a group-based, guided-self help intervention. Participants in this group will attend three online group sessions spread over six weeks (Week 1, Week 2, and Week 6) and complete homework between sessions. Following Session 3, there is a four week period where participants complete self-guided check-ins once per week to monitor continued progress and/or signs of relapse. | Behavioural | Binge Focused Therapy (BFT) |
| CBT Unguided Self Help (CBT USH)The CBT USH group will be provided with the book, Overcoming Binge Eating by C. Fairburn, which is a well-established self-help book used to help individuals understand binge eating and control binge eating behaviours. After participants receive the book, they will have 10 weeks to read it and work through the exercises provided in the book. | Behavioural | CBT Unguided Self Help (CBT USH) |
Primary outcome
Binge Eating Symptomology
Time frame: Baseline to Post-Treatment (10 week)
This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.
10 secondary outcomes
Binge Eating Symptomology
Time frame: 6 week, 6-month follow-up, 12-month follow-up
Binge Eating Frequency
Time frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)
Time frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Clinical Impairment
Time frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Confidence to Change Binge Eating
Time frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Abstinence
Time frame: Week 10, 6-month follow-up, 12-month follow-up
Remission
Time frame: Week 10, 6-month follow-up, 12-month follow-up
Intervention Adherence
Time frame: Week 6, Week 10
Participant Expectations
Time frame: Pre-Intervention, Week 1
Satisfaction with Intervention
Time frame: Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Keshen, MD, FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binge Focused Therapy (BFT) and CBT Unguided Self Help (CBT USH) in people with Binge Eating Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating Symptomology (time frame: Baseline to Post-Treatment (10 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023; AzTrials last refreshed its copy on 2 Nov 2026.